Shares of Amicus Therapeutics Inc. FOLD, -33.10% were down 23.1% in premarket trading on Friday, the day after the company said an experimental rare disease drug failed to perform better than the standard of care in a late-stage trial. The investigational drug, AT-GAA, is a treatment for Pompe disease, a rare, genetic disease that causes severe muscle weakness. The standard of care is Sanofi’s SNY, -0.94% Lumizyme, which was approved back in 2010. Though Amicus said it still plans to submit AT-GAA to the Food and Drug Administration for approval in the second quarter of 2021, analysts were concerned about the drug’s performance in the pivotal Phase 3 clinical trial. SVB Leerink on Friday downgraded the stock to market perform from outperform. “This situation strikes us as reminiscent of the long and arduous path to approval for FOLD’s one commercial product Amigal, which also missed its primary endpoint but was ultimately approved,” SVB’s Joseph Schwartz wrote in a note to investors. J.P. Morgan also downgraded the stock to neutral from overweight. “Certainly, overall, this is a disappointing outcome,” analysts there wrote. “That said, we do not view AT-GAA as a ‘zero’ by any means.” Shares of Amicus have gained 67.8% over the past 12 months, while the broader S&P 500 SPX, +0.11% is up 16.6%.
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